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| Dockets Entered
On July 18, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| 2001E-0032
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| Patent Extension for VISUDYNE, No. 5,095,030
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002E-0065
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| Patent Term Application for Kineret No. 5,075,222
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| 2002E-0097
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| Patent Term Application for Clarinex
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| 2002E-0340
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| Antagon, U.S. Patent No. 4,801,577
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| 2002E-0344
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| Patent Term Application for ATS Open Pivot Bileaf Valve 5,35
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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| 2003E-0033
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| Patent Extension Application for DERMAGRAFT No. 4,963,489
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| 2003E-0260
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| Patent Extension for Amevive (alefacept), 5,547,853
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0169
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| Dental Amalgam; Request for Information
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| |
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| |
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| 2003P-0176
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| Follow-Up Approval of Therapeutic Protein Products
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| 2004D-0509
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| Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
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| |
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| 2004E-0023
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| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| 2004E-0402
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| Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| |
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| |
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| |
|
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| 2004N-0558
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| Agency Information Collection Activities; Submission for Office
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| |
|
|
| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| |
|
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| |
|
|
| 2005D-0042
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| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings
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| |
|
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| |
|
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| |
|
|
| 2005E-0233
|
| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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|
| | | | | | | | |
| |
|
|
| 2005E-0234
|
| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| |
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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| |
|
|
| 2005E-0236
|
| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
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| |
|
|
| 2005E-0238
|
| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
|
| |
|
|
| 2005E-0239
|
| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| |
|
|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
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| |
|
|
| 2005E-0247
|
| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| |
|
|
| 2005E-0248
|
| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
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| |
|
|
| 2005E-0249
|
| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
|
| |
|
|
| 2005E-0251
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| |
|
|
| 2005E-0252
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
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| |
|
|
| 2005E-0253
|
| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| |
|
|
| 2005E-0254
|
| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
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| |
|
|
| 2005E-0255
|
| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
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| |
|
|
| 2005E-0256
|
| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
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| |
|
|
| 2005E-0259
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| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
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| |
|
|
| 2005N-0098
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| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
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| |
|
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| 2005N-0147
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| Sprout Safety Public Meeting
|
| |
|
|
| 2005P-0020
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| replace inacurate and/or misleading wording as unpasteurized and replace with the word untreated
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| |
|
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| 2005P-0114
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| ANDA for Ceftriaxone for injection, USP, pharmacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps
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|
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| 2005P-0140
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| ANDA Suitability for Oxycodone Hydrochloride, 7.5 mg Tablets, USP
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| |
|
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| 2005P-0176
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| make a determination that Cefditoren Pivoxil tablets, 400 mg is suitable for submission in an ANDA
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| 2005P-0179
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| ANDA suitability for ribavirin, USP tablets in a strength of 500 mg
|
| |
|
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| 2005P-0180
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| ANDA suitability for Hydrocodone Bitartrate and Ibuprofen Tablets in the following strength, 2.5 mg/ 200 mg
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| |
|
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| 2005P-0225
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| Oxycodone Hydrochloirde Controlled Release Tablets in strengths of 30 mg and 60 mg for ANDA
|
| |
|
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| 2005P-0282
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| Require Health Messages on Soft Drinks
|
| |
|
|
| 1995S-0158
|
| Community Disclosure of Institutional Review Boards
|
| |
|
|
| SUP 42
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| Northfield Laboratories Inc BB IND 10719
|
| Vol #:
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| 46
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7497
|
| J. Radke
|
| Vol #:
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| 319
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| |
|
|
| C 7498
|
| B. Lazarus
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| Vol #:
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| 319
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| |
|
|
| EMC 4338
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| S. Nauslar
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| Vol #:
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| 320
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| |
|
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| EMC 4339
|
| S. Bigontina
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| Vol #:
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| 320
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| |
|
|
| EMC 4340
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| D. Bugnitz
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| Vol #:
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| 320
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| |
|
|
| EMC 4341
|
| J. Miller
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| Vol #:
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| 320
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|
| | | | | | | | |
| |
|
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| EMC 4342
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| P. Jhabvala
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| Vol #:
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| 320
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| |
|
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| EMC 4343
|
| D. Evans
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| Vol #:
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| 320
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| |
|
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| EMC 4344
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| B. Gallen
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| Vol #:
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| 320
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| |
|
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| EMC 4345
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| J. Young
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| Vol #:
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| 320
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| |
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| EMC 4346
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| J. Young
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| Vol #:
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| 320
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| |
|
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| EMC 4347
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| J. DeSpain
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| Vol #:
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| 320
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|
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| EMC 4348
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| K. Crupi
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| Vol #:
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| 320
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| EMC 4349
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| E. Mace
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| Vol #:
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| 320
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| EMC 4350
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| C. Stahl
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| Vol #:
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| 320
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| EMC 4351
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| L. Hollings
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| Vol #:
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| 320
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| |
|
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| EMC 4352
|
| S. Wurl
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| Vol #:
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| 320
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|
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| EMC 4353
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| T. Triplett
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| Vol #:
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| 320
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| |
|
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| EMC 4354
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| L. Sislin
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| Vol #:
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| 320
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| |
|
|
| EMC 4355
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| G. Woodall
|
| Vol #:
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| 320
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| |
|
|
| EMC 4356
|
| K. Duke
|
| Vol #:
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| 320
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| |
|
|
| EMC 4357
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| Mr and Mrs J. Denison
|
| Vol #:
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| 320
|
| |
|
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| EMC 4358
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| S. Collier
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| Vol #:
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| 320
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| |
|
|
| EMC 4359
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| L. Skardinski
|
| Vol #:
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| 320
|
| |
|
|
| EMC 4360
|
| S. Lee
|
| Vol #:
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| 320
|
| |
|
|
| EMC 4361
|
| L. Shell
|
| Vol #:
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| 320
|
| |
|
|
| EMC 4362
|
| V. Lang
|
| Vol #:
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| 320
|
| |
|
|
| EMC 4363
|
| M. Edwards
|
| Vol #:
|
| 320
|
| |
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
| |
|
|
| EMC 614
|
| L. Olson
|
| Vol #:
|
| 30
|
| |
|
|
| 2001E-0032
|
| Patent Extension for VISUDYNE, No. 5,095,030
|
| |
|
|
| LET
5
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 2
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| EMC 3174
|
| R. Cowling
|
| Vol #:
|
| 261
|
| |
|
|
| EMC 3175
|
| M. Miller
|
| Vol #:
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| 261
|
| |
|
|
| EMC 3176
|
| R. South
|
| Vol #:
|
| 261
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1275
|
| R. Condon
|
| Vol #:
|
| 6
|
| |
|
|
| 2002E-0065
|
| Patent Term Application for Kineret No. 5,075,222
|
| |
|
|
| LET
5
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2002E-0097
|
| Patent Term Application for Clarinex
|
|
| |
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002E-0340
|
| Antagon, U.S. Patent No. 4,801,577
|
| |
|
|
| LET
5
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2002E-0344
|
| Patent Term Application for ATS Open Pivot Bileaf Valve 5,35
|
| |
|
|
| LET
4
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
| |
|
|
| TR
6
|
| FDA Outreach Meeting held in Atlanta
|
| Vol #:
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| 26
|
| |
|
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| TR
7
|
| FDA Outreach Meeting held in Minnesota
|
| Vol #:
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| 27
|
| |
|
|
| TR
8
|
| FDA Outreach Meeting held in California
|
| Vol #:
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| 28
|
| |
|
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| TR
9
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| FDA Outreach Meeting held in Missouri
|
| Vol #:
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| 29
|
| |
|
|
| TR
10
Continued
|
| FDA Outreach Meeting held in Maryland
|
| Vol #:
|
| 30
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 488
|
| Mission Possible International
|
| Vol #:
|
| 8
|
| |
|
|
| EMC
489
|
| Calorie Control Council
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 490
|
| Mission Possible International
|
| Vol #:
|
| 8
|
| |
|
|
| 2003E-0033
|
| Patent Extension Application for DERMAGRAFT No. 4,963,489
|
| |
|
|
| LET
6
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0260
|
| Patent Extension for Amevive (alefacept), 5,547,853
|
| |
|
|
| LET
5
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0410
|
| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
|
| |
|
|
| LET
4
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 826
|
| K. Honnen
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 827
|
| S. Verklan
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 828
|
| C. Spackman
|
| Vol #:
|
| 11
|
|
| |
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
| |
|
|
| EMC 293
|
| S. Scheckner, DMD
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 294
|
| Consumer for Dental Choice
|
| Vol #:
|
| 7
|
| |
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
| |
|
|
| EMC
8
|
| HBH Enterprises
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
| |
|
| 2003P-0176
|
| Follow-Up Approval of Therapeutic Protein Products
|
| |
|
|
| EMC
4
|
| Novartis Pharmaceuticals, Corp.
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0509
|
| Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
|
| |
|
|
| LET
1
|
| HFG-1 to European Commission
|
| Vol #:
|
| 1
|
| |
|
|
| REF
1
|
| FDA Clarifications Regarding 2003 Seafood Audit
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0023
|
| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
|
| |
|
|
| LET
6
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0402
|
| Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0279
|
| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
|
| |
|
|
| C
4
|
| Genzyme Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| AdvaMed
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
| |
|
|
| C 15
|
| M. Parisi,MD,MS,Ed
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 14
|
| J. Hung, PhD., BCNP
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
15
|
| Society of Nuclear Medicine
|
| Vol #:
|
| 2
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| EMC 1159
|
| D. Frantz
|
| Vol #:
|
| 29
|
| |
|
|
| EMC 1160
|
| H. Quintana
|
| Vol #:
|
| 29
|
| |
|
|
| EMC 1161
|
| A. Knauf
|
| Vol #:
|
| 29
|
| |
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
| EREG
1
|
| American Society for Clinical Nutrition
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0458
|
| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
|
| |
|
|
| EC
41
|
| human rights
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
| |
|
|
| EREG
4
|
| American Society for Clinical Nutrition
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0558
|
| Agency Information Collection Activities; Submission for Office
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
| | | | | | | | |
| |
|
|
| EMC
6
|
| Novartis Pharmaceuticals, Corp.
|
| Vol #:
|
| 2
|
| |
|
|
| 2004P-0223
|
| Whole Grain Descriptive Claims
|
| |
|
|
| C
22
|
| Archer Daniels Midland Company (ADM)
|
| Vol #:
|
| 5
|
|
| |
|
| 2004P-0520
|
| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
|
| |
|
|
| C
3
|
| Eon Labs, Inc. (Eon)
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
2
|
| Eon Labs, Inc. (Eon)
|
| Vol #:
|
| 2
|
| |
|
|
| 2005D-0042
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| Draft Guidance on the Open Public Hearing, FDA Advisory Committee Meetings
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| EMC
1
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| Public Citizen's Health Research Group
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| C
13
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| sanofi-aventis Group
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| Vol #:
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| 1
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| EMC
3
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| EMC
4
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| Society of Nuclear Medicine
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| Vol #:
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| 1
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| EMC
5
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2005D-0240
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| Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
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| EC
1
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| Consumer Healthcare Products Association
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| Vol #:
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| 1
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| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| |
|
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| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
|
|
| 2005E-0234
|
| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005E-0236
|
| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005E-0238
|
| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005E-0239
|
| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
| |
|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
| | | | | | | | |
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| |
|
| 2005E-0247
|
| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0248
|
| Patent Term Extension Application for Fosrenol, U.S. Patent No. 5,968,976
|
| |
|
|
| LET
2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
| |
|
| 2005E-0249
|
| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0251
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0252
|
| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-754), U.S. Patent No. 5,376,634
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0253
|
| Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498
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| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0254
|
| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0255
|
| Patent Extension Application for LUNESTA (exzoplclone), U.S. Patent No. 6,444,673
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005E-0256
|
| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| |
|
| 2005E-0259
|
| Patent Extension Application for EMTRIVA (emtricitabine), U.S. Patent No. 5,914,331
|
| |
|
|
| LET
3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2005N-0098
|
| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
|
| |
|
|
| EMC
1
|
| P/L Biomedical
|
| Vol #:
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| 1
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| |
|
|
| 2005N-0147
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| Sprout Safety Public Meeting
|
| |
|
|
| EC
3
Attachment
1, 2
|
| DAISEY MACHINERY CO., LTD.
|
| Vol #:
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| 1
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| |
|
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| EC
4
|
| Greensward / New Natives
|
| Vol #:
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| 1
|
| |
|
|
| 2005P-0020
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| replace inacurate and/or misleading wording as unpasteurized and replace with the word untreated
|
| |
|
|
| LET
1
|
| HFS-300 to Perricone Juices
|
| Vol #:
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| 1
|
| |
|
|
| 2005P-0114
|
| ANDA for Ceftriaxone for injection, USP, pharmacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps
|
| |
|
|
| PAV
1
|
| HFD-600 to Samson Medical Technologies, L.L.C.
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
| |
|
| 2005P-0140
|
| ANDA Suitability for Oxycodone Hydrochloride, 7.5 mg Tablets, USP
|
| |
|
|
| PAV
1
|
| HFD_600 to Lachman Consultant Services, Inc.
|
| Vol #:
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| 1
|
| |
|
|
| 2005P-0176
|
| make a determination that Cefditoren Pivoxil tablets, 400 mg is suitable for submission in an ANDA
|
| |
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
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| 1
|
|
| |
|
| 2005P-0179
|
| ANDA suitability for ribavirin, USP tablets in a strength of 500 mg
|
| |
|
|
| PAV
1
|
| HFD-600 to Kilpatrick Stockton LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0180
|
| ANDA suitability for Hydrocodone Bitartrate and Ibuprofen Tablets in the following strength, 2.5 mg/ 200 mg
|
| |
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0225
|
| Oxycodone Hydrochloirde Controlled Release Tablets in strengths of 30 mg and 60 mg for ANDA
|
| |
|
|
| PAV
1
|
| HFD-600 to The Weinberg Group Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0282
|
| Require Health Messages on Soft Drinks
|
| |
|
|
| C 1
|
| Form Letter
|
| Vol #:
|
| 2
|
| |
|
|
| C
2
|
| American Public Health Assn et al
|
| Vol #:
|
| 1
|
|
|
